Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022193
Company: ALCON PHARMS LTD

• Summary Review

Products on NDA 022193

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAVSTEL	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE	0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION;IRRIGATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022193lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022193s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022193_navstel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022193s000_SumR.pdf

Labels for NDA 022193

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022193lbl.pdf